As the nation grapples with opioid abuse and misuse, one drug maker has failed to provide the Food and Drug Administration with a required study about the effect its powerful painkiller might have on teenagers.
At issue is Xartemis XR, which Mallinckrodt Pharmaceuticals received regulatory approval to sell two years ago. At the time, the company was also required to conduct a so-called postmarketing study to determine its safety in youngsters between 12 and 17 years old, according to FDA documents (see page 11).
But as of June 24, the company blew past a March 31 deadline for submitting its pediatric assessment. The drug maker also failed to respond to an April 25 “noncompliance” letter for which the FDA provided a new 45-day deadline to either submit the data or request an extension, according to the notice posted on the FDA web site on Thursday.
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